Tag Archives: National

ARRL to Sponsor 2016 Atlantic Season Hurricane Webinar

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Arrl_logo The ARRL will sponsor a 2016 Atlantic Season Hurricane Webinar on Thursday, July 21, at 8 PM ET (0000 UTC on Friday, July 22, UTC). The approximately 90-minute session will address the role of Amateur Radio during the 2015 Hurricane Season. Anyone interested in hurricane preparedness and response is invited to attend this online presentation.

Topics will include a meteorological overview of the upcoming season; Amateur Radio station WX4NHC at the National Hurricane Center: Who We Are and What We Do; ARRL Media and Public Relations; the Hurricane Watch Net (HWN); the VoIP Hurricane Net, and ARRL coordination and interface.

The program will include presentations by representatives of the National Hurricane Center and WX4NHC, the VoIP Hurricane Net, the HWN, the Canadian Hurricane Centre, and the ARRL. Webinar registration is open to all, but should be of particular interest to radio amateurs in hurricane-prone areas. The webinar will conclude with a Q&A session.

For additional information, contact ARRL Emergency Preparedness Manager Mike Corey, KI1U.

From ARRL web site.

Museum Ship Amateur Radio event begins June 4

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logo-09The Museum Ships Weekend Event, sponsored by the Battleship New Jersey Amateur Radio Station, will begin Saturday, June 4 at 0000Z ending at 2359Z June 5th. Amateur operators will have the opportunity to contact almost 100 stations including retired ships from the U.S. Navy and Maritime service and Maritime museums.

On June 3, Ham operators can download an Excel spreadsheet of the participating stations from the New Jersey Amateur Radio Station web site.

The main operating modes will be single-side band (SSB) and International Morse Code (CW). There will be some PSK31 operations and some of the ships will fire up their origianl amplitude modulation (AM) equipment.

Interested Amateur radio operators can get more information and find contact information at the Battleship New Jersey Amateur Radio Station web site.

Exceptional Health Products Issues Allergy Alert On Undeclared Soy And Milk Allergens In Angel Wings™- Daily Multi 120 Capsules

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ucm497171Exceptional Health Products of Tulsa Oklahoma is recalling Angel Wings™ – Daily Multi 120 Capsules because this product contains undeclared SOY and MILK allergens. People who have an allergy or severe sensitivity to Soy or Milk allergens run the risk of serious or life-threatening allergic reaction if they consume this product.

The following product was distributed nationwide to consumers through mailorder.

Product Name: Angel Wings™ – Daily Multi 120 Capsules

Lot Numbers: 14656, 14657, 15109, 15489, 15488, 15616, and 16007

This voluntary recall has been initiated because this product contains undeclared SOY and MILK allergens. People who have an allergy or severe sensitivity to Soy or Milk allergens run the risk of serious or life-threatening allergic reaction if they consume this product.

No illnesses have been reported to date. This was brought to our attention by the Food and Drug Administration that found inconsistencies with our supplier’s allergen statement on the Amino Acid ingredients used in this formulation.

The recalled lot numbers began shipping nationwide on December 23, 2014. If you find the recalled lot numbers on the bottom of any bottle you have inventory you may return it to the address at the bottom for a full refund or replacement. If you have further distributed this product, please identify the recipients or your customers and notify them at once of this product recall.

If you have any questions, call 888-548-0477 Monday thru Friday 8:00 AM to 5:00 PM CST. We are sorry for this inconvience and appreciate your assistance.

Consumer Labels for Broadband Services

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Comparing prices, performance and network practices of broadband service providers can be challenging, even for savvy consumers. With this in mind, the FCC created Open Internet transparency rules requiring providers to convey sufficient information for consumers to make informed choices about available broadband services. Based on recommendations from its Consumer Advisory Committee, the FCC provides templates for broadband labels – one for landline and one for mobile – that service providers may use to supply consumers with information about their services.

If a provider uses a broadband label template, here’s the type of information you can expect to see:

  • Pricing details, including all of the various charges that seem mysterious to consumers – overage fees, equipment fees, early termination fees, other monthly fees beyond service fees such as insurance, administrative fees, or regulatory recovery fees.
  • Monthly data allowance – namely, the carrier-defined plan limit after which consumers will incur additional charges.
  • Broadband speed and other performance metrics.
  • Network management practices – namely, precautions providers may take to manage heavy traffic on their networks.

Service providers who use the labels will satisfy the FCC’s requirement to make transparency disclosures in the proper format, or a format that meets the needs of consumers. However, providers may still be in violation of FCC rules if the content of their labels is misleading or inaccurate or if they make misleading or inaccurate statements to customers in ads or elsewhere. In such cases, consumers can file complaints with the FCC at https://consumercomplaints.fcc.gov.

The new rules will go into effect later this year, but service providers may begin using the broadband label templates anytime. The labels can serve as a helpful comparison shopping tool for consumers. Look for and consider them when you shop for service.

More information

Voluntary Recall of Fetch™ 2 Aspiration Catheter

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MARLBOROUGH, Mass. – Boston Scientific (NYSE: BSX) has initiated a global, voluntary recall of all models of its Fetch™ 2 Aspiration Catheter, a thrombectomy catheter used during procedures to remove small blood clots from coronary arteries. The Fetch 2 catheters were recalled on March 22, 2016, due to complaints of shaft breakage. The U.S. Food and Drug Administration (FDA) classified the action as a Class 1 recall. This recall designation means that the use of the device exposes the patient to a reasonable chance of a serious adverse health consequence or death.

There have been no reports of patient injury or death, and there is no risk to patients who previously underwent a thrombectomy procedure with the Fetch 2 catheter. All reports of shaft breakage happened during the procedure, and the broken section was either removed while still partially attached to the catheter shaft or retrieved with a snare, without further patient complications. While unreported, the most severe potential outcome of this breakage is embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment surgically.

As part of the recall, all affected healthcare facilities were advised to discontinue use of all Fetch 2 catheters immediately and return unused product to Boston Scientific. Because Boston Scientific acquired the Fetch 2 catheter product line from Bayer Medical Care Inc., all recalled inventory is packaged and labeled as Bayer product. This device was manufactured between June 11, 2014 and February 19, 2016. There are currently 21,155 devices on the market subject to this recall.

Fetch 2 Catheter UPNs
FETCH2 US
109400-001
FETCH2 OUS
109400-002
FETCH2 Canada
109400-003
FETCH2 Japan
109400-004
FETCH2 EU
109400-005

Physicians and healthcare facilities can direct questions to their Boston Scientific representative or, call 1-800-811-3211. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
    or
  • Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to Boston Scientific by calling 1-800-811-3211 and to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

Vascular Solutions, Inc. Issues Recall of Guardian® II Hemostasis Valves

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On March 3, 2016, Vascular Solutions, Inc. (Nasdaq: VASC), initiated a nationwide recall of Guardian II hemostasis valves used in catheterization procedures. Specific lots of the products have been recalled because they pose an increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death. This recall only affects the Guardian II hemostasis valves and does not include the Guardian II NC hemostasis valves. No injuries have been reported in association with this issue to date.

Healthcare facilities that have the affected Guardian II hemostasis valves should remove the products from their inventory and return them to Vascular Solutions.

The recalled products were manufactured from March 2015 to February 2016 and distributed from April 2015 to February 2016.

The recalled products are specific lots of Model Numbers 8210 and 8211. A listing of the recalled lots is available from Vascular Solutions and has been provided to each facility that purchased the affected products. A total of 26,550 devices have been manufactured, with 5,283 distributed in the United States. The condition that led to the recall may affect approximately 2.4% of recalled devices.

Vascular Solutions Inc. voluntarily initiated the recall on March 3, 2016 through an Urgent Medical Device Recall notification distributed to purchasers of the affected products. The notification identified the specific lots subject to the recall and included instructions on how to return the affected products.

The U.S. Food and Drug Administration (FDA) classified this as a Class I recall. FDA defines Class I recalls as “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

Consumers with questions may contact the company by phone at 1-888-240-6001 Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time or by email at customerservice@vasc.com. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program:

For further information, connect to www.vasc.com.

Progressive Gourment Inc. Issues an Allergy Alert on Taste of Inspirations Edamame Rangoon

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ucm495082Progressive Gourmet Inc. of Wilmington, MA, is voluntarily recalling its frozen, 9 ounce packages of Taste of Inspirations Edamame Rangoon out of an abundance of caution because they have the potential to contain crustacean shellfish (crab). People who have an allergy to crustacean shellfish run the risk of serious or life-threatening allergic reaction if they consume these products. The item is produced for Hannaford Supermarkets.

The product comes in a 9 ounce carton, marked with Best Before: 1 1117 on the back of the retail carton. Note, no other production runs of this product are impacted by this recall.

The potentially impacted Edamame Rangoon were possibly sold to consumers at select Hannaford stores located in Maine, Massachusetts, New Hampshire, Vermont and New York.

A consumer reported the mislabeling incident. The firm has initiated prompt corrective actions to prevent future mislabeling. No illnesses have been reported to date in connection with this product.

Consumers who have purchased 9 ounce packages of the edamame rangoon are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-224-7630 (9:00 am – 5:00 pm Monday through Friday EST).

McCain Foods USA, Inc. Recalls Pork Products Due To Possible Foreign Matter Contamination

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McCain Foods USA, Inc., a Lisle, Ill. establishment, is recalling approximately 25,215 pounds of bacon fritters that may be contaminated with extraneous plastic materials, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The potato, egg, cheese, and bacon fritters were produced on Nov. 11, 2015. The following products are subject to recall:

1,681 cases bearing a batch code 1001487402 containing four 3.75-lb. plastic vacuum-packed packages containing “McCain EARLY RISERS Potato, Egg, Cheese & Bacon Fritters.”

The products subject to recall bear establishment number “EST. 18846” inside the USDA mark of inspection. These items were shipped to food service distributors in Arkansas, Florida, Iowa, Indiana, Illinois, Kansas, Maine, Oklahoma, Ohio, Texas, Tennessee, and Utah.

The problem was discovered after the firm received a consumer complaint and subsequently notified an in-plant FSIS inspector.

There have been no confirmed reports of adverse reactions due to consumption of these products. FSIS has received no additional reports of injury or illness from consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

Medical advisory on St. Jude Optisure dual coil defibrillation leads for implantable cardioverter defibrillators

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St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that a previously communicated voluntary global field safety action related to the company’s Optisure™ Dual Coil Defibrillation Leads has now been classified as a Class 1 Advisory by the U.S. Food and Drug Administration. The Class 1 Advisory relates to a limited and well-defined group of 447 Optisure leads, 278 of which were distributed in the U.S., which may have been damaged during a manufacturing step. The company has received no reports of lead malfunction or patient injury related to this issue and all physicians with patients impacted by this advisory have been notified.

Optisure dual coil defibrillation leads are used in conjunction with implantable cardioverter defibrillators (ICDs), which monitor the heartbeat of patients suffering from heart rhythm disorders. An ICD’s leads deliver electric current to the heart to help restore the heart to its normal rhythm when needed.

On November 3, 2015, St. Jude Medical began the global process of notifying physicians following patients who have been implanted with the 447 Optisure dual coil leads subject to this advisory. An investigation revealed a variation in the process to remove excess medical adhesive used in the assembly of the superior vena cava (SVC) shock coil in a limited and well-defined group of Optisure leads could result in cuts to the insulation of the lead. Depending on device programming and the depth of the inadvertent cut to the insulation, compromise of lead insulation can potentially lead to an electrical malfunction wherein the defibrillator cannot deliver appropriate high voltage therapy.

A St. Jude Medical internal investigation found the probability that a lead was damaged as a result of the manufacturing variation to an extent that it could result in the inability to deliver appropriate high voltage therapy is very low and that any associated risks can be prevented with device reprogramming. The patients’ leads can also be monitored from home using the Merlin.net™ remote care system. The company has not received any reports of compromised performance of the impacted Optisure leads. St. Jude Medical is in the process of providing an updated advisory notice to physicians to further ensure physicians are aware of recommendations for managing their patients who may have been implanted with the impacted leads.

The advisory notification involves the worldwide distribution of 447 Optisure dual coil defibrillation leads manufactured and distributed by St. Jude Medical. The advisory relates to units within the following models: LDA220, LDA220Q, LDA230Q, and LDP220Q.

The vast majority of patients implanted with the Optisure leads compromised by the advisory have devices equipped with the St. Jude Medical DynamicTx™ feature that provides additional protection to help ensure delivery of appropriate high voltage therapy even in the case of a compromised lead. For these patients, physicians are advised to enroll patients in the Merlin.net patient care network, ensure the DynamicTx feature is programmed “on” and then monitor patients as per normal follow-up protocols.

Physicians following the 9 patients in the U.S. with compromised leads not connected to a device with the DynamicTx feature have been advised to enroll these patients in the Merlin.net patient care network and, where appropriate, consider turning off the SVC coil. If a dual coil shocking configuration is desired, physicians should consider performing a high voltage test when clinically appropriate to determine whether the lead has been compromised. As of this letter all physicians following the 9 patients have been contacted and provided information about this event.

Patient safety is St. Jude Medical’s highest priority, and the company will continue to work closely with customers and global regulatory agencies to ensure effective communication to our physician partners. The company has alerted all physician customers impacted by the advisory by letter, and all leads subject to this advisory have been accounted for and none remain in any field distribution. The U.S. Food and Drug Administration and other regulatory bodies have been notified. For more information, patients or their physicians can visit www.sjm.com/optisureadvisorydisclaimer icon or call the St. Jude Medical customer service team 24 hours a day at (800) 328-9634.

Whole Foods Recalls Frozen Pizza Products Due to Misbranding

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Whole Foods/North Atlantic Kitchens, an Everett, Mass. establishment, is recalling approximately 73,898 pounds of pepperoni pizza products due to misbranding, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product is labeled as containing uncured beef pepperoni. However, the pizzas contain uncured pork pepperoni, which is not declared on the product label. Some individuals have a sensitivity or intolerance to pork.

The fresh pizza items were produced Jan. 5, 2015, through Jan. 22, 2016.
pizza

  • 10-oz. vacuum-sealed packages of “WHOLE FOODS MARKETS, PIZZA, PEPPERONI, 8”.
  • 19-oz. vacuum-sealed packages of “WHOLE FOODS MARKETS, PIZZA, PEPPERONI, 12”.

The products subject to recall bear establishment number “EST. 20234” inside the USDA mark of inspection and Sell-by dates of Jan. 12, 2015 through Jan. 30, 2016 printed on the packaging. These items were shipped for wholesale and retail sale in Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, and Rhode Island.

The problem was discovered by FSIS during a label review at the establishment and occurred as a result of a change in ingredient suppliers.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.